Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03513601
• Other study ID #: hnslblzlzx2017-10
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2017
• Est. completion date: May 2019

Study information

• Verified date: April 2018
• Source: Zhengzhou University
• Contact: Mingzhi zhang, Pro,Dr
• Phone: 13838565629
• Email: Mingzhi_zhang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore the clinical features and efficacy evaluation of large b-cell lymphoma in old age.

Description:

The results of the analysis of the treatment of large b-cell lymphoma in old age were analyzed, and the treatment of large B cell lymphoma was provided.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 85 Years

Eligibility

Inclusion Criteria:

• Above 70 years old,Pathology proved to be diffuse large B cell lymphoma,Estimated survival time > 3 months,None of chemotherapy contraindication;At least one measurable lesion according to RECIST;None of other serious diseases;Patients could be followed up;None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.

volunteers who signed informed consent.

Exclusion Criteria:

• Currently undergoing chemotherapy, radiotherapy and targeted therapy (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or has not recovered from any previous treatment of acute toxicity);Patients with uncontrolled medical problems (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia, etc.); Pregnant or lactating women;Serious medical illness likely to interfere with participation;Chemotherapy contraindication such as cachexia; patients with other malignancies previously;Serious infection;The evidence of peripheral nervous disorder or dysphrenia; patients estimated to be unsuitable by investigator.

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• (R)-CHOP regimen
(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1?8 ivgtt,epirubicin 50mg/m2 d1?8 ivgtt,vincristine 2mg d1?8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and six cycles are required. Efficacy was evaluated every two cycles.
• (R)-CVP regimen
The dose of the chemical was reduced by 20%,(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1?8 ivgtt,vincristine 2mg d1?8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and one or two cycles are required. Efficacy was evaluated every two cycles. Subsequent (rituximab 375mg/m2 d0 ivgtt), oral cyclophosphamide .

Locations

Country	Name	City	State
China	Oncology Department of The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Mingzhi Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Progression-free survival	up to end of follow-up-phase(approximately 24 months)
Secondary	overall survival	overall survival	up to the date of death (approximately 5 years)
Secondary	disease control rate	disease control rate	every 6 weeks,up to completion of treatment(approximately 18 weeks )]
Secondary	objective remission rate	objective remission rate	every 6 weeks,up to completion of treatment(approximately 18 weeks )]